#18721
Re: Novavax (NVAX): Un Nuevo Comienzo
Stan como comunicador es muy deficiente. Discurso inconexo, dubitativo, monótono... Le está costando mucho dinero a la empresa. Como he dicho otras veces, si en vez de este tenemos el de Moderna el precio habría tocado $500 seguro.
En la EC no dice apenas nada de los problemas en US, muchas cosas en el aire. Va aclarando algo en las diversas entrevistas (la de Yahoo es buena), primero que si la segunda generación de validación para la FDA, luego que la FDA no tiene que ver con la parada y es el USG y que no va a soltar pasta para la fabricación y entregar la documentación a la FDA hasta que Texas no arregle sus problemas, sobre los que Novavax no puede hacer mucho (y podrían tardar meses en solucionar depende de lo que sea). Son dos cosas distintas, la validación y la fábrica de Texas pero ambas parece que paran la aprobación y una sí que depende de Novavax. Pero no está muy claro porque Stan balbucea respuestas y en estos casos no es nada claro.
Con lo fácil que hubiera sido decir algo como esto en la EC (de IV):
The OWS is the program manager and they are the ones controlling the timeline. Novavax was directed to work with Fujifilm TX per OWS, and there was quality issues during initial FDA inspections. We are working closely with the CMO and the FDA. And Fujifilm TX is doing a wonderful job of rectifying the issues and you are waiting for OWS to give the green light for FDA reinspection prior to US FDA filing. There is no disagreements or issues with the FDA because Novavax has very high quality standards and no lots of material will be shipped without proper quality assurances. We are in the process of developing next generation assays to make sure we are in full compliance. Currently, we are not making any bulk antigen from the Fujifilm TX plant, and are focusing all of our resources to resolve all FDA inspection findings. We anticipate a few weeks delay per OWS program managers, and this has unfortunately pushed us back into October 2021 filing in the US. This has no impact to the MHRA or EU applications since Fujifilm TX will not be supplying those regions as we have diversified our contractor base, and our EU CMO partners will supply that region. The MHRA application is on track for September filing. We look forward to the exciting path forward as multiple filing and EUA is granted. We have 100M doses in bulk antigen ready to go by end of August, and will have an run rate of 100M run rate by September ramping up to 150M run rate by December. We expect quick approval by the 3 countries that we have submitted with SII, and we will have vaccines in those countries by end of September or October 2021!
https://www.investorvillage.com/smbd.asp?mb=193&mn=138760&pt=msg&mid=22277051
En la EC no dice apenas nada de los problemas en US, muchas cosas en el aire. Va aclarando algo en las diversas entrevistas (la de Yahoo es buena), primero que si la segunda generación de validación para la FDA, luego que la FDA no tiene que ver con la parada y es el USG y que no va a soltar pasta para la fabricación y entregar la documentación a la FDA hasta que Texas no arregle sus problemas, sobre los que Novavax no puede hacer mucho (y podrían tardar meses en solucionar depende de lo que sea). Son dos cosas distintas, la validación y la fábrica de Texas pero ambas parece que paran la aprobación y una sí que depende de Novavax. Pero no está muy claro porque Stan balbucea respuestas y en estos casos no es nada claro.
Con lo fácil que hubiera sido decir algo como esto en la EC (de IV):
The OWS is the program manager and they are the ones controlling the timeline. Novavax was directed to work with Fujifilm TX per OWS, and there was quality issues during initial FDA inspections. We are working closely with the CMO and the FDA. And Fujifilm TX is doing a wonderful job of rectifying the issues and you are waiting for OWS to give the green light for FDA reinspection prior to US FDA filing. There is no disagreements or issues with the FDA because Novavax has very high quality standards and no lots of material will be shipped without proper quality assurances. We are in the process of developing next generation assays to make sure we are in full compliance. Currently, we are not making any bulk antigen from the Fujifilm TX plant, and are focusing all of our resources to resolve all FDA inspection findings. We anticipate a few weeks delay per OWS program managers, and this has unfortunately pushed us back into October 2021 filing in the US. This has no impact to the MHRA or EU applications since Fujifilm TX will not be supplying those regions as we have diversified our contractor base, and our EU CMO partners will supply that region. The MHRA application is on track for September filing. We look forward to the exciting path forward as multiple filing and EUA is granted. We have 100M doses in bulk antigen ready to go by end of August, and will have an run rate of 100M run rate by September ramping up to 150M run rate by December. We expect quick approval by the 3 countries that we have submitted with SII, and we will have vaccines in those countries by end of September or October 2021!
https://www.investorvillage.com/smbd.asp?mb=193&mn=138760&pt=msg&mid=22277051
